ENRICH Nurse-Family Partnership Study

NCT05798039 | Recruiting DMC

• 2 other identifiers: 22-0021UG3HL162967
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The overarching goal of the proposed study is to develop and test an enrichment to Nurse-Family Partnership (NFP) using an existing, evidence-based program to improve clients' and their children's cardiovascular health from early pregnancy to 24 months postpartum. With support from NFP supervisors and nurses, the investigators will develop new NFP materials promoting healthy diet, activity, sleep, and smoking behaviors, along with optimal weight, glycemia, lipid, and blood pressure profiles. The investigators will conduct a pilot study with up to 40 NFP clients (or women similar to NFP client population) and their nurses to determine feasibility and acceptability of the materials and study protocol.

Conditions

Blood Pressure; Body Composition; Blood Sugar; Body Weight; Diet Habit; Physical Inactivity

Outcome Measures

Primary Outcomes (1)

• Maternal BMI

  Height and weight will be measured and combined to report BMI

  Enrollment

Secondary Outcomes (7)

• A1C

  Enrollment

• Blood pressure

  Enrollment

• Diet Quality

  Enrollment

• Physical Activity

  Enrollment

• Smoking frequency

  Enrollment

Study Arms (1)

ENRICHed NFP

EXPERIMENTAL

Participants will receive additional heart health-focused materials and guidance in sessions with their nurse home visitor. The nurse will help them choose and work towards behavior goals to support their health. This will include goals for activity, diet, weight, blood pressure, diabetes, smoking, social relationships, sleep, parenting, and getting health care.

Behavioral: ENRICH

Interventions

ENRICH BEHAVIORAL

Participants will receive additional heart health-focused materials and guidance in sessions with their nurse home visitor. The nurse will help them choose and work towards behavior goals to support their health. This will include goals for activity, diet, weight, blood pressure, diabetes, smoking, social relationships, sleep, parenting, and getting health care.

Also known as: NFP-Heart

ENRICHed NFP

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant or \<24 months postpartum
• Aged 18 years or older
• English- or Spanish-speaking

You may not qualify if:

• \<18 years old

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Denver Health and Hospital Authority: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Body Weight; Feeding Behavior; Sedentary Behavior

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Officials

• Mandy Allison, MD, MSPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

720-957-5161; enrich@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 4, 2023
• Study Start: June 19, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)